Safety and Efficacy of a Non-Invasive 1060 nm Diode Laser for Fat Reduction of the Abdomen

January 2018 | Volume 17 | Issue 1 | Original Article | 106 | Copyright © January 2018


Lawrence S. Bass MD FACSa and Sean T. Doherty MD FACSb

aDepartment of Plastic Surgery, Manhattan Eye, Ear & Throat Hospital, Hofstra Northwell School of Medicine, New York, NY bDivision of Plastic Surgery, Department of Surgery, Emerson Hospital, Concord, MA

Abstract
BACKGROUND: Changes in temperature are known to produce apoptosis in adipocytes. This study examines the use of a non-invasive treatment that applies 1060 nm laser energy transcutaneously to hyperthermically induce disruption of fat cells in the abdomen. METHODS: Thirty-five subjects received application of 1060 nm laser on the abdomen for fat reduction. Ultrasound images and high-resolution two-dimensional photography were recorded at baseline, 6 weeks, and 12 weeks post treatment. Subjects maintained a stable diet and exercise routine throughout the course of the study. Weight was recorded at baseline and each follow-up visit. Three board certified dermatologists were trained as blinded evaluators and tasked with identifying before and after photographs from randomized, paired baseline, and 12-week photographs. Ultrasound images were used to measure the fat thickness change from baseline at 6 and 12 weeks. Level of patient satisfaction was graded at 12 weeks using a 6 point Likert scale. REULTS: 23% of subjects were Fitzpatrick IV-VI. Blinded evaluators correctly identified the post-treatment photograph 95% of the time (88%, 97%, and 100%). Mean reduction in fat layer thickness from baseline was statistically significant (P less than 0.001) at both 6 weeks (1.5 +/-1.23 mm) and 12 weeks (2.65 +/-1.41 mm). Mean weight change was +0.1 lb. Side effects were mild to moderate including edema, tenderness, and induration mostly resolving within 1-3 weeks post treatment. No serious adverse events were reported. CONCLUSION: 1060 nm based laser treatment can consistently reduce the fat contour in the abdomen with an excellent safety profile in all skin types. The study met all three of its prospectively defined endpoints of success.

J Drugs Dermatol. 2018;17(1):106-112.

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INTRODUCTION

Body contouring with liposuction is consistently one of the two most popular aesthetic surgical procedures.1 More recently, a number of options for non-invasive body contouring have become available. These have been even more popular and show a double-digit growth of 18.7% in 2015 compared to the prior year.1 This demand is fueled by the growing desire to avoid invasive procedures where possible.Some non-invasive fat reduction options create immediate necrosis of adipocytes due to tissue coagulation.2 Others achieve a similar endpoint with cavitation.3 An alternative strategy creates adipocyte damage that is sub-lethal, resulting in apoptosis over time. This endpoint can be produced using tissue heating or tissue cooling. Laboratory studies have demonstrated the ability to produce apoptosis in a high percentage of the adipocyte population heating to temperatures of 42-47 C for a period of 15 minutes.4 A variety of energy sources can potentially be used to produce such heating. Preliminary laboratory and clinical studies demonstrated the ability to damage adipocytes using a 1060 nm diode laser device to target this endpoint.4,5This study reports the experience of using a non-invasive 1060 nm diode laser device in the pivotal clinical trial for safety and efficacy of fat layer reduction in the abdomen that has since been approved by FDA for this indication.

PATIENTS AND METHODS

Study DeviceThe device used in this study provided 1060 nm diode laser light exposure through a 4X6 cm optical window that was simultaneously cooled with circulating fluid to 15ºC (Cynosure, Westford, MA). The treatment head was held in contact with the skin overlying the targeted fat using straps passed around the subject’s waist. Energy densities ranging from 0.9-1.4 W/cm2 were used.Study DesignA prospective controlled study was conducted at two centers, with each enrolled patient receiving a single non-invasive treatment. Institutional review board approval of the protocol was obtained and patients signed an informed consent form.This study included subjects who had to be healthy males or females between 20 and 65 years of age with a BMI of 32 or under and with unwanted fat in the abdominal region. Subjects were excluded for a variety of conditions including skin hypersentivities, anti-coagulant, or anti-platelet therapies, previous surgery, or liposuction in the treatment area, pregnancy, or a history of
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